NCT06849401

The Safety and Efficacy of VGO-Cs01p in Patients With CD7-positive Relapsed/Refractory Acute T-lymphoblastic Leukemia

A Single-arm, Open Label Clinical Study to Evaluate the Safety and Efficacy of VGO-Cs01p in Patients With CD7-positive Relapsed/Refractory Acute T-lymphoblastic Leukemia

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if the VGO-Cs01p can help to control CD7-positive relapsed/refractory acute T-lymphoblastic leukemia (R/R T-ALL) in children.

Detailed description

This is a single-arm, open label, IIT clinical trial to evaluate the safety and efficacy of CD7 CAR NK cells in subjects with CD7-positive relapsed/refractory acute T-lymphoblastic leukemia (R/R T-ALL). 5\~9 subjects plan to be enrolled. In this study, safety and efficacy results will be used for dose escalation design at the same time, and three initial dose groups are set up. All subjects will be followed up to 12 months after infusion.

Conditions

• T-ALL

Interventions

Type	Name	Description
BIOLOGICAL	VGO-Cs01p	Off-the-shelf NK cell products derived from human embryonic stem cells (hESCs)

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-08-01
• Completion: 2026-10-01
• First posted: 2025-02-27
• Last updated: 2025-05-15